A Randomized Phase 2 Study of Ipilimumab, Nivolumab, and Brentuximab Vedotin in Patients with Relapsed Hodgkin Lymphoma - PubMed

3 months ago

A Phase 2 study (E4412) evaluated nivolumab (Nivo), ipilimumab (Ipi), and brentuximab vedotin (BV) in relapsed/refractory Hodgkin lymphoma (HL).
147 patients were randomized into BV/Nivo or BV/Ipi/Nivo arms, with 132 included in efficacy analysis.
Complete response (CR) rates were 64.7% for BV/Nivo and 70.3% for BV/Ipi/Nivo (p=0.29).
Median survival follow-up was 38.0 months, with no significant difference in progression-free survival (PFS) between arms (HR=0.78, p=0.24).
Grade 3+ toxicities were similar (38.5% BV/Nivo vs. 39.3% BV/Ipi/Nivo), but BV/Ipi/Nivo had higher grade 3 rash (24.6% vs. 9.2%).
Post-hoc analysis showed 36-month PFS >90% for both arms in patients who underwent stem cell transplantation (SCT).
For non-SCT patients, 36-month PFS was higher with BV/Ipi/Nivo (73.0%) vs. BV/Nivo (45.8%) (HR=0.45, p=0.03).
The study did not meet its primary endpoint but supports checkpoint-ADC induction before SCT and suggests disease control benefits for BV/Ipi/Nivo in deferring/avoiding SCT.

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